BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1191529 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07197
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 3, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE FOLLOWING BLOOD GLUCOSE COMPARISONS WERE OBTAINED ON THE ACCU-CHEK INFORM SYSTEM: 502MG/DL AND 102MG/DL, "HI" (GREATER THAN 600MG/DL) AND 85 MG/DL, "HI" (GREATER THAN 600MG/DL) AND 182MG/DL, AND "HI" (GREATER THAN 600MG/DL) AND 182MG/DL. ALL AFOREMENTIONED TESTS WERE OBTAINED WITHIN 10 MINUTES. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. THE SUSPECTED PRODUCT IS UNAVAILABLE FOR RETURN; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP. 550077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK